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CSV Engineers plan, write, implement and review the Computer Systems Validation protocols in place within highly regulated manufacturing industries. Their work is essential to make sure that all computer-based systems are operating as intended (with documents to prove it) and meet regulatory requirements. What is CSV? Computer Systems Validation (CSV) is a process used to ensure (and document) that all computer-based systems will produce information or data that meet predefined requirements. If a system meets these requirements, it can be assumed that it is consistently performing in the way it was intended. The process is used within highly regulated environments that directly impact public health and safety such as pharmaceutical and medical device manufacturing. In these industries, it’s crucial that any process within the manufacturing cycle reliably behaves in a consistent way. Pharmaceutical manufacturing and medical device manufacturing industries are increasingly relying on computer systems to operate a range of manufacturing processes, so it’s more important than ever that these systems can be relied upon to follow a predetermined specification. It is also a requirement of the industry’s compliance requirements, to ensure the safety of the final product.